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Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia (TRANSHEMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02866526
Recruitment Status : Unknown
Verified January 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Severe haemophilia is a rare disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. Due to advances in medical care and more specifically in the development of prophylactic strategies by the application of clotting factor concentrates, life expectancy of persons with severe haemophilia has significantly increased over the last decades. This progress requires a long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up and to a prophylactic treatment then depends on how successful patients' transition from childhood to adulthood has been as this process involves a transfer of responsibility from parents to patients concerning the management of their health. Beyond the issue of patients' adherence, a suboptimal transition may also impair quality of life and the entry into adulthood, especially at the social, emotional and professional levels. Only a few studies have been conducted to identify the specific needs and difficulties young persons with severe haemophilia experience during their transition from childhood to adulthood, and none of these studies has been carried out in France where the features of the health care system are very specific.

Therefore, this study aims to address the issue of transition into adulthood among young persons with severe haemophilia in France. This study will focus not only on the facilitators and barriers of the access to health care but also, from a more global perspective, on all the specific concerns and difficulties they may experience as they grow into adulthood which may impair their long-term health related quality of life as well as their personal empowerment. This study will also allow to identify some of the socio- cognitive, emotional, and familial determinants of a good transition into adulthood.


Condition or disease Intervention/treatment
Haemophilia Other: Patient questionnaire

Detailed Description:

The main objective of this study is to assess the impact of transition from adolescence into adulthood especially on adherence to health care, among young people with severe haemophilia in France.

The operational objectives of this study are: i) to compare the level of adherence in adolescents and in young adults (YA) ii) to identify determinants (medical, organisational, socio-demographic and social, and psychosocial and behavioural factors) of the level of adherence in YPWH (young people with haemophilia), iii) to assess specific factors involved in suboptimal level of adherence in the sub-groups of adolescents on one hand and of YA on the other hand, iv) to identify groups of patients (clusters) regarding both their level of adherence and their psychosocial characteristics, v) to examine trough a qualitative approach YPWH needs and expectations towards the health care system during the transition process, and to identify some ways to improve their global care.

This study is an exploratory, observational, multicentric, transversal study aimed at describing the perceptions of adolescents (14-17 years old) with severe haemophilia to those of young adults (20-29 years old) regarding their expectations and their feelings about growing into adulthood. Every patient enrolled in the FranceCoag national cohort (cohort of French patients suffering from inherited deficiencies of coagulation proteins), suffering from severe haemophilia, aged from 14 to 17 years old or from 20 to 29 years old, will be offered to get enrolled in the TRANSHEMO study (expected number eligible of participants: 154 adolescents and 389 young adults). , among whom 70% are expected to take part in the study). The patients' participation in this study will not modify their medical or paramedical care. A multifocal approach which combines both quantitative and qualitative data collection will be proposed.

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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia - TRANSHEMO
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
group1
adolescents (14-17 years old)
Other: Patient questionnaire
quantitative and qualitative data collection will be proposed.

group 2
young adults (20-29 years old)
Other: Patient questionnaire
quantitative and qualitative data collection will be proposed.




Primary Outcome Measures :
  1. Number of follow-up visits / theoretical number of follow-up visits over the last two years [ Time Frame: Two years ]
    Adherence to clinical follow-up

  2. Number of injections of prophylactic treatment realized / theoretical number of injections of prophylactic treatment over the last three months [ Time Frame: 3 months ]
    Adherence to prophylactic treatment


Secondary Outcome Measures :
  1. Patient-reported adherence [ Time Frame: one day ]
    Specific item of the patient questionnaire (0-10 points)

  2. Physician-reported adherence of the patient [ Time Frame: one day ]
    Specific item of the medical questionnaire (0-10 points)

  3. Number of haemorrhagic events [ Time Frame: one day ]
    Specific item of the medical questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cohort of persons with severe haemophilia
Criteria

Inclusion Criteria:

  • Patients with severe haemophilia
  • Patients enrolled in the FranceCoag national cohort
  • Patients aged from 14 to 17 years old (adolescents group) or from 20 to 29 years old (young adults group)
  • Adults patients having given their agreement to participate in the study, or minor patients authorized to participate in the study by their parents or their legal representatives

Exclusion Criteria:

  • Patients with comprehension problems
  • Patients unable to read or to write
  • Adults patients not having given their agreement to participate in the study, or minor patients unauthorized to participate in the study by their parents or their legal representatives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866526


Contacts
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Contact: Noémie RESSEGUIER 0491324272 ext +33 noemie.resseguier@ap-hm.fr

Locations
Show Show 29 study locations
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES ASSISTANCE Publique Hôpitaux de Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866526    
Other Study ID Numbers: 2016-30
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique Hopitaux De Marseille:
adolescents
young adults
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn